BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P110008 · Supplement: S005 · Decision Aug 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    COFLEX® INTERLAMINAR TECHNOLOGY
    PMA Number
    P110008
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    NQO
    Generic Name
    Prosthesis, spinous process spacer/plate
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 23, 2016
    Date Received
    March 9, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the manufacturing sites located at 6688 Dixie Highway, Bridgeport, MI 48722 for the packaging and labeling of the coflex Interlaminar Technology; 11911 Clark Street, Arcadia, CA 91006 for the laser marking, in-process cleaning, and inspection of the coflex Interlaminar Technology; and 1880 Industrial Drive, Libertyville, IL 60048 for the sterilization of the coflex Interlaminar Technology.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQO Prosthesis, Spinous Process Spacer/Plate